Conformis, Inc. Announces Clearance in Australia for iTotal® PS, the Only Personalized, Posterior-Stabilized Total Knee Repl...
March 01 2021 - 5:45PM
Conformis, Inc. (NASDAQ: CFMS) today announced the clearance
of its patient-specific iTotal® PS total knee replacement system by
the Therapeutic Goods Administration, which is part of the
Australian Department of Health, and which authorizes the marketing
of medical devices and other healthcare products in Australia.
The iTotal® PS system, which launched in the United States in
2016, is designed to address the shortcomings of traditional,
off-the-shelf knee replacements that are manufactured in limited
sizes and shapes. iTotal® PS implants are specifically designed to
restore the natural shape of each patient’s knee, and to avoid
overhang, rotation, and sizing compromises associated with pain
after surgery. Primary total knee implants are designed to either
retain the patient’s own posterior cruciate ligament
(cruciate-retaining, or CR), or substitute for it
(posterior-stabilized, or PS). iTotal® PS implants use a customized
cam and spine feature to serve the function of the posterior
cruciate ligament and to provide optimal stability throughout the
full range of motion.
“Receiving clearance for our iTotal® PS product in Australia
will allow us to offer a best-in-class, patient-specific solution
to relieve patients’ chronic knee joint pain,” said Mark Augusti,
President and CEO. “With this clearance, we have greatly expanded
the number of potential patients who will be candidates for our
personalized knee replacement implants, and we are thrilled to
offer the benefits of our unique technology to surgeons in
Australia who prefer a posterior-stabilized design to a
cruciate-retaining one.”
iTotal® PS is designed with the following features and
benefits:
- patient-specific femoral and tibial fit to avoid overhang,
under-coverage, and sizing compromises;
- patient-specific shape designed to provide stability throughout
the range of motion and to restore kinematics;
- patient-specific cam and spine to provide optimal stability and
to reduce the potential for a “mechanical” feel;
- pre-operative surgical plan to enable a predictable,
reproducible knee replacement procedure; and
- a safe and simple delivery model that includes a single
pre-sterilized kit, a single reusable instrument tray, and no
implant inventory.
The global knee joint reconstruction market is projected at more
than $9 billion. HCF, Australia’s largest nonprofit health
insurer, reports that more than 50,000 knee replacement procedures
are performed in Australia each year.
About Conformis, Inc.
Conformis is a medical technology company that uses its
proprietary iFit® Image-to-Implant® technology platform to develop,
manufacture, and sell joint replacement implants and instruments
that are individually sized and shaped, which it refers to as
personalized, individualized, or sometimes as customized, to fit
and conform to each patient’s unique
anatomy. Conformis offers a broad line of sterile,
personalized knee and hip implants and single-use instruments
delivered to hospitals and ambulatory surgical
centers. In clinical studies,
the Conformis iTotal® CR knee replacement system
demonstrated superior clinical outcomes, including better function
and greater patient satisfaction, compared to traditional,
off-the-shelf implants. Conformis owns or exclusively
in-licenses issued patents and pending patent applications that
cover personalized implants and patient-specific instrumentation
for all major joints.
For more information, visit www.conformis.com. To receive
future releases in e-mail alerts, sign up
at http://ir.conformis.com.
Cautionary Statement Regarding Forward-Looking
Statements
Statements in this press release about our future expectations,
plans and prospects, as well as other statements containing the
words “anticipate,” “believe,” “continue,” “could,” “estimate,”
“expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,”
“project,” “should,” “target,” “will,” or “would” and similar
expressions, constitute forward-looking statements within the
meaning of the safe harbor provisions of The Private Securities
Litigation Reform Act of 1995. You should not place undue reliance
on our forward-looking statements. Actual results could differ
materially from the projections disclosed in the forward-looking
statements we make as a result of a variety of risks and
uncertainties, including risks and uncertainties described in the
“Risk Factors” sections of our public filings with
the Securities and Exchange Commission. In addition, the
forward-looking statements included in this press release represent
our views as of the date hereof. We anticipate that subsequent
events and developments may cause our views to change. However,
while we may elect to update these forward-looking statements at
some point in the future, we specifically disclaim any obligation
to do so. These forward-looking statements should not be relied
upon as representing our views as of any date subsequent to the
date hereof.
Source: Conformis, Inc.
CONTACT:
Investor Relations
ir@conformis.com
(781) 374-5598
Conformis (NASDAQ:CFMS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Conformis (NASDAQ:CFMS)
Historical Stock Chart
From Apr 2023 to Apr 2024